Model Number OER-PRO |
Device Problem
Inadequate or Insufficient Training (1643)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Customer stated she was advised to contact the olympus technical assistance center (tac) to walk through changing the pre-filters when ready.Tac explained the maj-824 filter had to be changed every six months.Tac explained how the pressure drops on the prefilter and how to make an adjustment.Tac emailed customer the consumable list with instructions and part numbers for filters.Tac directed customer how to find steps on how to change the six month filter and provided the olympus web site information of how to download quick reference guide.Issue resolved over tac phone call.No further information was reported.
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Event Description
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The customer called olympus for guidance on changing the filter in the oer-pro.The user reported that the filter was being changed for the first time one week short of a year.The customer was not aware of the frequency for changing the filters.There was no patient injury reported.
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Manufacturer Narrative
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The investigation has been completed.A device history record (dhr) was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.Instructions for use (ifu) states: ¿replace the water filter at least once a month to prevent contamination of the rinse water.Using at least a prefilter (0.45 micron or less) can extend the life of the water filter.¿ during the investigation it was confirmed that the device had been used at the user facility longer than the recommended period.Related to report mfr: 8010047 -2020 -05619.
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Search Alerts/Recalls
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